MRI compatible surgical biopsy device

ABSTRACT

A biopsy device which is compatible for use with a magnetic resonance imaging machine. The device includes a non-metallic elongated substantially tubular needle having a distal end for insertion within tissue, a proximal end, and a longitudinal axis therebetween. The needle comprising right and left members on either side of the longitudinal axis, wherein the right and left members each having upper and lower ends comprising a series of alternating male and portions. The male portions of the right member mate with the female portion of the left member, and the male portions of the left member mate with the female portions of the right member to securely attach the two members together. He device further includes a port on the elongated needle for receiving a tissue sample.

FIELD OF THE INVENTION

[0001] The present invention relates, in general, to devices for tissuesampling and, more particularly, to improve biopsy probes for acquiringsubcutaneous biopsies and for removing lesions.

BACKGROUND OF THE INVENTION

[0002] The diagnosis and treatment of patients with cancerous tumors,pre-malignant conditions, and other disorders has long been an area ofintense investigation. Non-invasive methods for examining tissue arepalpation,Thermography, PET, SPECT, Nuclear imaging, X-ray, MRI, CT, andultrasound imaging. When the physician suspects that tissue may containcancerous cells, a biopsy may be done either in an open procedure or ina percutaneous procedure. For an open procedure, a scalpel is used bythe surgeon to create a large incision in the tissue in order to providedirect viewing and access to the tissue mass of interest. Removal of theentire mass (excisional biopsy) or a part of the mass (incisionalbiopsy) is done. For a percutaneous biopsy, a needle-like instrument isused through a very small incision to access the tissue mass of interestand to obtain a tissue sample for later examination and analysis. Theadvantages of the percutaneous method as compared to the open method aresignificant: less recovery time for the patient, less pain, lesssurgical time, lower cost, less risk of injury to adjacent bodilytissues such as nerves, and less disfigurement of the patient's anatomy.Use of the percutaneous method in combination with artificial imagingdevices such as X-ray and ultrasound has resulted in highly reliablediagnoses and treatments.

[0003] Generally there are two ways to percutaneously obtain a portionof tissue from within the body, by aspiration or by core sampling.Aspiration of the tissue through a fine needle requires the tissue to befragmented into small enough pieces to be withdrawn in a fluid medium.The method is less intrusive than other known sampling techniques, butone can only examine cells in the liquid (cytology) and not the cellsand the structure (pathology). In core sampling, a core or fragment oftissue is obtained for histologic examination, genetic tests, which maybe done via a frozen or paraffin section. The type of biopsy useddepends mainly on various factors present in the patient, and no singleprocedure is ideal for all cases. However, core biopsies seem to be morewidely used by physicians.

[0004] Recently, core biopsy devices have been combined with imagingtechnology to better target the lesion. A number of these devices havebeen commercialized. One such commercially available product is marketedunder the trademark name MAMMOTOME™, Ethicon Endo-Surgery, Inc. Anembodiment of such a device is described in U.S. Pat. No. 5,526,822issued to Burbank, et al., on Jun. 18, 1996, and is hereby incorporatedherein by reference.

[0005] As seen from that reference, the instrument is a type ofimage-guided, percutaneous, coring, breast biopsy instrument. It isvacuum-assisted, and some of the steps for retrieving the tissue sampleshave been automated. The physician uses this device to capture“actively” (using the vacuum) the tissue prior to severing it from thebody. This allows for sampling tissues of varying hardness. The devicecan also be used to collect multiple samples in numerous positions aboutits longitudinal axis, and without removing the device from the body.These features allow for substantial sampling of large lesions andcomplete removal of small ones.

[0006] Co-pending application Ser. No. 08/825,899 filed on Apr. 2, 1997,which is hereby incorporated herein by reference, described otherfeatures and potential improvements to the device including a moldedtissue cassette housing permitting the handling and viewing of multipletissue samples without physical contact by the instrument operator.Another described therein is the interconnection of the housing to thepiercing needle using a thumbwheel, to permit the needle to rotaterelative to the housing, and preventing the vacuum tube from wrappingabout the housing. During use, the thumbwheel is rotated so that thedevice rotates within the lesion, and samples can be taken at differentpoints within the lesion.

[0007] In actual clinical use for breast biopsy the instrument (probeand driver assembly) is mounted to the three axis-positioning head of anx-ray imaging machine. The three axis-positioning head is located in thearea between the x-ray source and the image plate. The x-ray machinesare outfitted with a computerized system which requires two x-ray imagesof the breast be taken with the x-ray source at two different positionsin order for the computer to calculate x, y and z axis location of thesuspect abnormality. In order to take the stereo x-ray images the x-raysource must be conveniently movable. The x-ray source therefore istypically mounted to an arm which, at the end opposite the x-ray source,is pivotally mounted to the frame of the machine in the region of theimage plate.

[0008] Recently, there has been a need for a hand held core samplingbiopsy device. This need has been fulfilled by Ethicon-Endo-Surgery inU.S. Pat. No. 6,086,544 issued on Jul. 11, 2000, which is herebyincorporated herein by reference. The aforementioned patent discloses ahand held MAMMOTOME™, The aforementioned invention is handpiece in thatthe handpiece on the MAMMOTOME™ may be held approximately parallel tothe chest wall of the patient for obtaining tissue portions closer tothe chest wall than my be obtained when using an instrument that may beobtained when using an instrument that is mounted is manipulated by theoperator's hand rather than by an electromechanical arm. Thus, theoperator may steer the tip of the handpiece on the MAMMOTOME™ with greatfreedom towards the tissue mass of interest. The surgeon has tactilefeedback while doing so and can thus ascertain to a significant, degree,the density and hardness of the tissue being encountered. In addition, ahand held MAMMOTOME™ is desirable because the handpiece on theMAMMOTOME™ may be held approximately parallel to the chest wall of thepatient for obtaining tissue portions closer to the chest wall than maybe obtained when using an instrument that is mounted to anelectromechanical arm.

[0009] Recently, there has been a desire to use the above describedbiopsy devices with MRI imaging devices instead of x-ray imagingdevices. However, existing medical biopsy sampling devices use small,multi-lumen probes extensively fabricated mostly if not entirely frommetal. The metallic nature of these probes has many drawbacks. Typicallythese metal probes are electrically conductive and often magneticallyweak, which interferes with their use under MRI guidance. Theelectrically conductive and magnetically weak nature of metal probesoften work to create field distortions, called artifacts, on the image.The image of the lesion will show the metal probe, and this isproblematic because the image of the probe can obscure the image of thelesion. Therefore, there has been a desire to have generallynon-metallic biopsy probe of the type described above. However,elimination of the artifact created by the metal probe entirely is alsoproblematic because physicians rely extensively on some type of artifactto notify them as to where the tip of the probe is relative to thelesion.

SUMMARY OF THE INVENTION

[0010] In accordance with the present invention there is provided abiopsy device, which is compatible for use with a magnetic resonanceimaging machine. The device includes a non-metallic elongatedsubstantially tubular needle having a distal end for insertion withintissue, a proximal end, and a longitudinal axis therebetween. The needlecomprising right and left members on either side of the longitudinalaxis, wherein the right and left members each having upper and lowerends comprising a series of alternating male and portions. The maleportions of the right member mate with the female portion of the leftmember, and the male portions of the left member mate with the femaleportions of the right member to securely attach the two memberstogether. The device further includes a port on the elongated needle forreceiving a tissue sample.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The novel features of the invention are se forth withparticularity in the appended claims. The invention itself, however,both as to organization and methods of operation, together with furtherobjects and advantages thereof, may best be understood by reference tothe following description, taken in conjunction with the accompanyingdrawings in which:

[0012]FIG. 1 is an isometric view of a hand held vacuum assisted biopsydevice constructed in accordance with a preferred embodiment of thisinvention.

[0013]FIG. 2 is an isometric view of the elongated needle of the handheld vacuum assisted biopsy device of FIG. 1.

[0014]FIG. 3 is an isometric view of the right body member of theelongated needle of the hand held vacuum assisted biopsy device ofFIG. 1. A cutter tube liner is illustrated in assembly with theelongated needle.

[0015]FIG. 4 is an exploded isometric view of the separated left bodymember and right body member of the elongated needle of the hand heldvacuum assisted biopsy device of FIG. 1.

[0016]FIG. 5 is an exploded isometric view of the two member needle tipon the elongated needle of the hand held vacuum assisted biopsy deviceof FIG. 1 as viewed from the proximal side thereof.

[0017]FIG. 6 is an exploded isometric view of the two member needle tipof the elongated needle of the hand held vacuum assisted biopsy deviceof FIG. 1 as viewed from the distal end thereof.

DETAILED DESCRIPTION OF THE INVENTION

[0018]FIG. 1 shows a hand-held vacuum assisted biopsy device 10comprising a needle assembly 20 and a holster 15. Needle assembly 20 isdetachably connected to holster 15. Together they constitute alightweight, ergonomically shaped, hand manipulatable portion referredto as handpiece 12. Since handpiece 12 is manipulated by the operator'shand rather than by an electromechanical arm, the operator may steer thehandpiece 12 with great freedom towards the tissue mass of interest. Thesurgeon has tactile feedback while doing so and can thus, ascertain to asignificant degree, the density and hardness of tissue beingencountered. In addition, handpiece 12 may be held approximatelyparallel to the chest wall of a patient for obtaining tissue portionscloser to the chest wall than may be obtained when using an instrumentmounted to an electromechanical arm.

[0019] The device includes a means for obtaining a tissue sample.Holster 15 includes a forward button 16 which may be used to move cutter21 (shown in FIG. 1) distally though cutter lumen 32 and sever tissuecollected in port 36. Holster 15 further includes a reverse button 17which may be used to move cutter 21 proximally through cutter lumen 32and thereby moving the tissue sample in port 36 to a tissue collectionsurface 19. A vacuum button 18 on holster 15 is used to open or closefirst and second vacuum lines, 27 and 28, for activating a vacuum lumen34 so as to cause tissue to become disposed within port 36.

[0020] Referring now to FIG. 2 there is shown an isometric view of theneedle assembly 20 of the hand held vacuum assisted biopsy device 10 ofFIG. 1. Needle assembly 20 includes an elongated needle 30 having adistal end 31, a proximal end 33 and a longitudinal axis therebetween.Needle assembly 20 has a needle tip 60 at its distal end for penetratingthe soft tissue of a surgical patient. Elongated needle 30 comprises acutter lumen 32 and a vacuum chamber lumen 34.

[0021] At the distal end of the elongated needle 30 is a needle tip 60,which is sharpened and is preferably made from an MRI compatible resinsuch as Ultem or Vectra. Needle tip 60 is designed to penetrate softtissue, such as the breast of a female surgical patient. In thisembodiment, needle tip 60 is a three-sided pyramidal shaped point,although the needle tip 60 configuration may also have other shapes.

[0022] Referring now to FIG. 3, elongated needle 30 is preferably madefrom a thermoplastic material such as Vectra A130 or B130 liquid crystalpolymer, although other MRI compatible resins may be available fromTicona of Summit, N.J. Elongated needle 30 includes a cutter lumen 32which houses the cutter 21 (shown in FIG. 1). Adjacent the distal end 31of the cutter lumen 32 is a port 36 for receiving the tissue that isextracted from a surgical patient by the cutter 21. Joined alongside thecutter lumen 32 is a vacuum chamber lumen 34. The vacuum chamber lumen34 receives vacuum from the second vacuum line 28 which is connected thevacuum chamber lumen 34 on the elongated needle 30 by the vacuummanifold 26 which is located at the proximal end 33 of elongated needle30. Also located at the proximal end of the elongated needle 30 is aflange 38, which allows the elongated needle 30 and needle assembly 20to interlock with the handpiece 12 on the hand-held vacuum assistedbiopsy device 10. Changing from a stainless steel needle to a polymermay require a change in wall thickness, for example from 0.008″ to0.030″. The liner 22, discussed below, is also made from a MRIcompatible material, preferably a polypropylene such as Proleneavailable from Ethicon, Inc., Somerville N.J., or a material known asRadel-5000, available from British Petroleum, London UK.

[0023] As seen in FIG. 4, elongated needle 30 is formed from a left bodymember 40 and a right body member 50 on either side of the longitudinalaxis. The edges of the halves 40 and 50 are gated for easy part filling,and the edges are stepped with ridges that allow the two halves 40 and50 to attach together with ease. Preferably needle 30 is molded from avery stiff thermoplastic, such as Vectra A130 or Vectra B130 liquidcrystal polymer. Other glass fiber reinforced resins known to thoseskilled in the art could also be used. Preferably the probe is made froma polymer material having the combination of high stiffness, lowviscosity, and low mold shrink rate, such as LCP resins.

[0024] During assembly of one potential embodiment the elongated needle30, the left body member 40 and right body member 50 of the elongatedneedle 30 are pushed together. Once the left body member 40 and theright body member 50 are pressed together, a thin-walled sleeve of highstrength tubing is slipped over the elongated needle and is shrinkfitted into place. The shrink tubing holds the left body member 40 andthe right body member 50 together for easier handling prior to adhesivecuring. In addition, the shrink tubing makes the exterior of theelongated needle 30 smoother for reduced insertion forces. (show shrinktubing in FIG. 2)

[0025] Referring back to FIG. 3, there is shown the right body member 50of the elongated needle 30, separated from the left body member 40,which has been omitted from this figure for clarity. The right bodymember 50 has upper and lower ends comprising alternating male andfemale portions or members, 42 and 52, which alternate and are arrangedaxially along the length of the right body member 50 of the elongatedneedle 30. In addition to the male and female members, 42 and 52, thereis an upper female distal member 54 and a lower male distal member 45,both of which are located at he distal end of the right body member 50.The upper female distal member 54 is located just below the distal endof the cutter lumen 32 and above the distal end of the vacuum chamberlumen 34. At the proximal end of the right body member 50 are threefemale receivers 56 which surround the vacuum manifold 26 at theproximal end of the right body member 50.

[0026] Still referring to FIG. 3, needle 20 includes a cutter tube liner22, which helps keep adhesive out of the lumen to provide a smoothsurface thereon. Liner 22 generally abuts in the inner surface of cutter20 along lumen 32. The distal end 31 of liner 22 is proximal to port 36but otherwise is disposed along the length of lumen 32. The cutter tubeliner 22 is formed from a thin-walled extrusion of a low-friction,abrasion-resistant plastic, such as polypropylene, polyetherimide orpolyethersulfone. The cutter tube liner 22 provides a smooth,low-friction, abrasion-resistant surface for the cutter 21. The cuttertube liner 22 also acts as an aid for sealing vacuum and fluid leakagein that it isolates the cutter lumen 32 from the vacuum chamber lumen 34and ensures that fluid and material from the cutter lumen 32 does notget sucked into the vacuum chamber 34 by vacuum suction in the vacuumchamber lumen 34. Isolating the cutter lumen 32 from the vacuum chamberlumen 34 may be preferable because the cutter lumen 32 and vacuum line27, and the vacuum chamber lumen 34 operates on the second vacuum line28.

[0027] Still referring to FIG. 3, another feature that is included inthe preferred design of the invention to enhance performance is theoutside diameter of the left body member 40 and right body member 50could be stepped very slightly, if needed, to compensate for thethickness of the cutter tube inner 22. This is, the cutter lumen 32would be very slightly larger than the inside diameter of the cuttertube liner 22, which is a thin walled structure.

[0028] Referring again to FIG. 4 there is shown an exploded isometricview of the elongate needle 30 of the and held vacuum assisted biopsydevice 10 of FIG. 1. Both the left body member 40 and the right bodymember 50 of the elongated needle 30 are shown. The female features 52,which are arranged axially on the right body member 50. Also, the malefeatures 42, which are arranged axially on the left body member 40, mateto the female features 52, which are arrange axially on the right bodymember 50. Also, the male features 42 are arranged axially on the rightbody member 50 mate to the female features 52 which are arranged axiallyon the left body member 40.

[0029] In addition to male and female members, 42 and 52, which arearranged axially and mate, the left body half 40 and right body member50 have additional features that mate at both the proximal and thedistal ends. At the proximal end of the right body member 50 are threefemale receivers 56 which surround the vacuum manifold 26. At theproximal end of the left body member 40 are three male bosses 46 whichsurround the vacuum manifold 36 and correspond to the three femalereceivers 56 on the right body member 50. When the left body member 40and the right body member 50 are pushed together, the three femalereceivers 56 on the proximal end of the left body member 40. Theproximal end of the elongated needle 30 is thus, retained by the threefemale receivers 56 and three male bosses 46, which mate at the proximalend of the elongated needle 30.

[0030] The needle tip 60 at the distal end of the elongated needle 30 isretained by the upper female distal part 54 and the upper male distal 44and the lower female distal portion 55 on the left body member 40. Onthe left body member 40 is and upper male distal portion 44 and a lowerfemale distal part 55. The upper male distal portion 44 is located abovethe cutter lumen 32 at the distal end on the left body member 40, andthe lower female distal part 55 is located below the cutter lumen 32 andabove the vacuum chamber lumen 34 at the distal end of the left bodymember 40. On the right body 50 is an upper female distal part 54 and alower male distal portion 45, which correspond to the upper male distalportion 44 and the lower female distal part 55 on the left body member40. The upper female distal part 54 is located above the cutter lumen 32at the distal end of the right body member 50, and the lower male distalportion 45 is located below the cutter lumen 32 and above the vacuumchamber lumen 34 at the distal end of the right body member 50.

[0031] Still referring to FIG. 4, not only do the male and femalemembers, 42 and 52, secure the body of the elongated needle 30, and theproximal and distal ends of the elongated needle 30, both female andfemale members, 42 and 52, also form the interlumen vacuum holes 23,which are located below the port 36 on the distal end of the elongatedneedle 30. The male and female members 42 and 52, on the right bodymember 50, which are located below the port 36 in between the cutterlumen 32 and vacuum chamber lumen 34, mate with a male and femalemembers, 42 and 52, on the left body member 40, which are also locatedbelow the port 36 in between the cutter lumen 36 and vacuum chamberlumen 34. When these male and female members, 42 and 52, on the leftbody member 40 and right body member 50 mate, the interlumen vacuumholes 23 on the needle 30 are formed. The interlumen vacuum holes 23 aresix cylindrically shaped holes which are open to port 36, so that thetissue can be severed by the cutter 21, which rotates and advances. Thecutter 21 deposits the tissue into the tissue collection surface 19 byretracting proximally.

[0032] Still referring to FIG. 4, during assembly of the elongatedneedle 30, sufficient adhesive is applied to the left body member 40 andright body member 40 and right body member 50, to fill the narrow axialspaces between the male and female members, 42 and 52, which mate. Afterthis, the left body member 40 and right body member 50 are pressedtogether. The adhesive that is used should be cured using light, heat,or other appropriate means for the particular types of adhesive that isbeing used. For a light cured adhesive, light could be directed insideof the cutter lumen 32 and the vaccum lumen 34 using light stick opticsif necessary.

[0033] Still referring to FIG. 4, the male and female members, 42 and52, which mate and are located on the left body member 40 and the rightbody member 50 have a number of distinct advantages. The male and femalemembers, 42 and 52, on the left body member 40 and right body member 50orient the left body member 40 and right body member 50 during assemblyof the elongated needle 30.

[0034] The male and female members, 42 and 52, which mate, are also keyfactors in increasing both the strength and lateral bending stiffness ofthe elongated needle 30. When the needle 30 is subjected to a lateralbending moment, nearly all of the material being loaded axially is thehigh-strength, high stiffness body material. Only the small amount ofadhesive that is used to fill the axial clearances between the male andfemale members, 42 and 52, which mate, is of a lower stiffness. Aconventional bonded joint would result in the bond line being loaded ina manner similar to that used for adhesive peel strength testing, whichis the most severe type of loading for an adhesive joint. In contrast tothis, the male female members, 42 and 52, which mate, would createlateral bond surfaces along the elongated needle 30. This substantiallyincreases the bond line length of the elongated needle 30. Because ofsignificant portions of the bond line being loaded in shear, thestrength and lateral stiffness of the elongated needle 30 is increased.This is improved over a single piece molded cylinder in that with thebond line loaded in shear, the elongated needle 30 will be able tosustain bending moments of its joints rather than at its base, whichdecreases the possibility of breakage.

[0035]FIG. 5 shows and exploded isometric view of the needle tip 60 ofthe elongated needle 30 of the hand held vacuum assisted biopsy device10 of FIG. 1 as viewed from the proximal side thereof. The needle tip 60has two halves; a composite tip member 70, and a composite hub member80. Both the composite tip member 70 and the composite hub member 80 arepreferably molded from a magnetic Resonance Imaging (MRI) compatibleresin such as Ultem or Vectra ceramic or other MRI compatible materialsknown to those skilled in the art is sharp. The composite tip member 70has a three-sided pyramidal shaped point, but may also have othershapes. The composite tip member 70 has a hollow cavity 74 andprotruding connectors 76. The two protruding connectors 76 are insertedinto the two receiving holes 82 on the composite hub member 80 when thecomposite hub member 80 is pushed into the composite tip member 70during assembly. Cavity preferably contains a capsule 90 made from amaterial which will leave and MRI artifact. Having a capsule 90 madefrom and MRI artifact leaving material is necessary because since theelongated needle 30 is made of an MRI compatible resin, the elongatedneedle 30 does not show up on an MRI scan. Therefore, it is difficultfor a physician to discern the orientation of the elongated needle 30during and MRI scan MRI artifact leaving material 90 solves theaforementioned problems in that a needle tip 60 leaves a small, but nottroublesome artifact on an MRI scan. This small, artifact indicates theorientation of the elongated needle 30 relative to the sight of biopsy,and where the tissue receiving bowl begins during and MRI scan. The MRIartifact leaving material 90 that is preferred is a capsule ofGadolinium. However, there are other materials that could be put intothe hollow cavity74 of the composite tip member 70 that would leave andacceptable MRI artifact. These include, but not limited to: liquidGadolinium, Titanium Wire, Aluminum, Copper, Brass Iron, and Bronze.

[0036]FIG. 6 shows an exploded isometric view of the needle tip 60 ofthe elongated needle 30 of the hand held vacuum assisted biopsy device10 of FIG. 1 as viewed from the distal end thereof. This figure clearlyillustrated the components on the composite hub member 80. On the distalend of the composite hub member 80 is a male part 84, which pushes theMRI artifact leaving material 80 down into the hollow cavity 74 on thecomposite tip member 70. Also located on the distal end of the compositehub member 80 is a knock out boss 86, which pushes a collected breasttissue sample into the end of the cutter tube 21 the hand held vacuumassisted biopsy device 10 during a breast biopsy. The two receivingholes 82 on the composite hub member 80 receive the two protrudingconnectors 76 on the composite tip member 70 when the composite tipmember 70 and composite hub member 80 are pushed together. The receptionof the two protruding connectors 76 on the composite tip member 70 bythe two receiving holes 82 on the composite hub member 80 locks thecomposite tip member 70 and the composite hub member 80 together, andseals the MRI artifact leaving material 90 in the hollow cavity 74 inbetween the composite tip member 70 and composite hub member 80.

[0037] In using the hand member vacuum assisted biopsy device 10, asshown in FIG. 1, for a breast biopsy in an MRI environment, physicianwill first positioned outside of the MRI magnet, the patient is movedinto the MRI magnet and imaging of the breast is performed. Duringimaging of the breast, serial slices of the breast are examined, and acontrast agent is administered to highlight suspicious areas of breasttissue. At this time, the location of the suspicious breast tissue isdetermined relative to the compression grid.

[0038] After the location of the suspicious breast tissue is determined,the patient is moved outside the magnet. Local anesthesia isadministered to the patient and the probe 20 is inserted into the areaof suspicious breast tissue.

[0039] After the probe is inserted into the suspicious area of breasttissue, the patient is moved back into the MRI magnet and a set ofimages of the breast are taken. The sets of images confirm that theprobe 20 is adjacent to the suspicious breast tissue, the patient ismoved outside of the MRI magnet and the hand held vacuum assisted biopsydevice 10 of FIG. 1 is then inserted into the sleeve, replacing theobturator.

[0040] After the hand held vacuum assisted biopsy device 10 of FIG. 1 isinserted through the sleeve; multiple tissue samples are taken. Intaking multiple tissue samples, the needle tip 60 as the distal end ofthe elongated needle 30 on the hand held vacuum assisted biopsy 10, ofFIG. 1, penetrates the breast in the area that is adjacent of thesuspicious breast tissue. Prior to, and during penetration by the needletip 60, the cutter 21 is fully forward, and is advanced forward throughthe cutter lumen 32 by pressing the forward button 16 on the holster 15of the vacuum assisted biopsy device 10 of FIG. 1.

[0041] Once the elongated needle 30 is positioned in the area adjacentto the suspicious breast tissue, vacuum suction is applied to he vacuumchamber lumen 34. The vacuum suction is applied by pressing the vacuumbutton 18 on the holster 15 of the hand held vacuum assisted biopsydevice 10 of FIG. 1. Pressing the vacuum button 18 on the holster 15opens the second vacuum line 28, which transports vacuum suction throughthe handpiece 12 of the hand held vacuum assisted biopsy device 10 andinto the vacuum chamber lumen 34 on the elongated needle 30. The secondvacuum line 28 runs through the handpiece 12 of the hand held vacuumassisted biopsy device 10 and into the elongated needle 30 through thevacuum manifold 24 at he proximal end of the elongated needle 30. Thevacuum suction that is applied to the vacuum chamber lumen travels fromthe proximal, of the distal end of the vacuum chamber lumen 34, belowthe interlumen vacuum holes 23. The interlumen vacuum holes 23 receivesuction from the vacuum chamber lumen 34.

[0042] The suction from the interlumen vacuum holes 23 actively pullsbreast tissue through the port 36 and into the cutter lumen 32 on theelongated needle 30. After the breast the tissue is pulled into theelongated needle 30 through the port 36, the cutter 21 begins to rotateand advances through the breast tissue until a sample has been obtained.After the breast tissue sample has been obtained, the elongated needle30 is rotated to position the port 36 toward a different clockwiseposition in preparation for obtaining the next tissue sample. After theelongated 30 is rotated, the cutter 21 is withdrawn backwards within thecutter lumen 32 on the elongated needle 30 and the breast tissue sampleis carried back to a knock-out boss 86, which pushed the collectedbreast tissue sample out into a tissue collection surface 19 on thehandheld vacuum assisted biopsy device 10. Vacuum suction is thenreapplied to the vacuum chamber lumen 34 from the second vacuum line 28,and the aforementioned process is repeated continuously until theelongated needle 30 has been rotated clockwise once around the entireclock.

[0043] After multiple breast tissue samples have been obtained from thepatient, the patient is moved back into the MRI magnet. Once in the MRImagnet, a set of images of the breast are taken in order to confirm thatthe suspicious breast tissue has been removed. The artifact in the probetip is a useful point of reference to confirm after the biopsy site ismarked, the breast biopsy in an MRI environment is complete.

[0044] While preferred embodiments of the present invention have beenshown and described herein, it will be obvious to those skilled in theart that such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the present invention. Accordingly, itis intended that the invention be limited only by the spirit and scopeof the appended claims.

What is claimed is:
 1. A biopsy device which is compatible for use witha magnetic resonance imaging machine, said device comprising: a. annon-metallic elongated substantially tubular needle having a distal endfor insertion within tissue, a proximal end, and a longitudinal axistherebetween, said needle comprising right and left members on eitherside of said longitudinal axis, said right and left members each havingupper and lower ends comprising a series of alternating male andportions, wherein said male portions of said right member mate with saidfemale portion of said left member and said male portions of said leftmember mate with said female portions of said right member to securelyattach said two members together; and b. a port on said elongated needlefor receiving a tissue sample.
 2. The device of claim 1 wherein saidneedle comprises a thermoplastic.
 3. The device of claim 1 wherein saidneedle comprises a glass fiber reinforced polymer resin.
 4. The deviceof claim 1 further including a sleeve disposed over said needle.
 5. Thedevice of claim 1 wherein said sleeve comprises high strength shrinkfitted tubing.
 6. The device of claim 1 wherein adhesive is disposed onsaid upper and lower ends of said needle for attachment to one another.7. The device of claim 1 wherein said needle has a longitudinal lumenextending therein, and said lumen having a liner extending therethrough.8. A biopsy device which is compatible for use with a magnetic resonanceimaging machine, said device comprising: a. a handle and an non-metallicelongated substantially tubular needle having a proximal end attached tosaid handle, a sharp distal end for insertion within tissue, and alongitudinal axis therebetween; b. said needle comprising right and leftmembers on either side of said longitudinal axis, said right and leftmembers each having upper and lower ends comprising a series ofalternating male and portions, wherein said male portions of said rightmember mate with said female portion of said left member and said maleportions of said left member mate with said female portions of saidright member to securely attach said two members together; and c. ameans for obtaining a tissue sample within said elongated needle.
 9. Thedevice of claim 8 wherein said needle comprises a thermoplastic.
 10. Thedevice of claim 8 wherein said needle comprises a glass fiber reinforcedpolymer resin.
 11. The device of claim 8 further including a sleevedisposed over said needle.
 12. The device of claim 8 wherein said sleevecomprises high strength shrink fitted tubing.
 13. The device of claim 8wherein adhesive is disposed on said upper and lower ends of said needlefor attachment to one another.
 14. The device of claim 8 wherein saidneedle has a longitudinal lumen extending therein, and said lumen havinga liner extending therethrough.
 15. A biopsy device which is compatiblefor use with a magnetic resonance imaging machine, said devicecomprising: a. a handle and an non-metallic elongated substantiallytubular needle having a proximal end attached to said handle, a sharpdistal end for insertion within tissue, and a longitudinal axistherebetween comprising a lumen, said needle further including a portfor receiving a tissue sample; b. said needle comprising right and leftmembers on either side of said longitudinal axis, said right and leftmembers each having upper and lower ends comprising a series ofalternating male and portions, wherein said male portions of said rightmember mate with said female portion of said left member and said maleportions of said left member mate with said female portions of saidright member to securely attach said two members together; and c. acutter for obtaining a sample of tissue which is disposed within saidport.
 16. The device of claim 15 wherein said needle comprises athermoplastic.
 17. The device of claim 15 wherein said needle comprisesa glass fiber reinforced polymer resin.
 18. The device of claim 15further including a sleeve disposed over said needle.
 19. The device ofclaim 15 wherein said sleeve comprises high strength shrink fittedtubing.
 20. The device of claim 15 wherein adhesive is disposed on saidupper and lower ends of said needle for attachment to one another.